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New Treatments for Troublesome Bleeding in Implanon Users

Primary Purpose

Menstrual Problem

Status
Unknown status
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Marvelon
Sponsored by
Family Planning Association New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menstrual Problem focused on measuring Implanon users, Frequent bleeding, Prolonged bleeding, Comparison of treatments, Placebo controlled, Randomly allocated tretment

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy women aged 18-45 using the subdermal progestogen-only contraceptive implant and experiencing frequent or prolonged vaginal bleeding Willing to keep a menstrual diary for 6 months

Exclusion Criteria:

Women who have currently or previously had

  • Heart attack or stroke
  • Blood clot in a vein
  • High blood pressure
  • Severe liver or kidney disease
  • Blood pressure > 135 mm systolic or >85 mm diastolic
  • Migraine with aura
  • Breast cancer or any genital cancer
  • Severe chronic liver or kidney disease
  • Women with known sensitivity to ethinyl oestradiol, progestogens
  • Women taking phenytoin, carbamazepine or phenobarbitol
  • Women who are pregnant
  • Women who are lactating
  • Women who are unwilling to keep a daily menstrual diary or otherwise unwilling to follow the study criteria

Sites / Locations

  • Sydney centre for Reproductive Health Research, FPNSW

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group 1 Marvelon ,placebo

Marvelon

NuvaRing

Starch capsule

Arm Description

7 days daily intake of oral capsule containing "Marvelon" ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms followed by 14 days oral placebo capsules containing starch for 21 day treatment Cycle

21 days daily intake of oral capsules containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms for one cycle of 21 days

21 days NuvaRing contraceptive vaginal ring releasing ethinyl oestradiol 15micrograms plus etonorgestrel 120 micrograms dailyleft in situ for 21 days Treatment will be for 21 days

21 days daily oral placebo capsules Treatment will be for one 21 day cycle

Outcomes

Primary Outcome Measures

The number of days to stop bleeding after initiation of each treatment group and placebo
The number of days to stop bleeding after initiation of each treatment group and placebo determined from menstrual diaries completed by subjects

Secondary Outcome Measures

The mean total number of bleeding and spotting days during the 90 day "treatment" reference period
The mean total number of bleeding and spotting days during the 90 day "treatment" reference period compared with the pre-treatment reference period (calculated as percentage reduction) for each group and a comparison between treatment groups and placebo and compared to the other treatment groups determined from menstrual diaries kept for 90 days prior to starting treatment and for 90 days from initiation of treatment.

Full Information

First Posted
June 27, 2011
Last Updated
June 28, 2011
Sponsor
Family Planning Association New South Wales
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01384331
Brief Title
New Treatments for Troublesome Bleeding in Implanon Users
Official Title
Phase 4 Study Comparison of Two Combined Oral Contraceptive Regimens and an Intravaginal Hormonal Ring Against Placebo for Management of Bleeding Problems in Women Using Implanon, the Sub-dermal Contraceptive Implant
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Family Planning Association New South Wales
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Most Implanon users experience a reduction in the frequency and volume of menstrual bleeding, but a substantial minority experience unpredictable and frequent and/or prolonged episodes of bleeding. This is a double blind, placebo controlled, randomised study with an additional randomised non-blinded arm. Two hundred women between the ages of 18-45 years, who are Implanon users with prolonged or frequent breakthrough bleeding (WHO definition) will be recruited and randomised into 4 equal-sized treatment groups of 50 women assigned to Marvelon 7 days or 21 days, NuvaRing 21 days or placebo. Recruited subjects will maintain a daily menstrual diary chart for a minimum of 90 days prior to randomisation, and will be enrolled into the treatment phase provided that they have met one of the World Health Organization criteria for prolonged or frequent bleeding Following the initial 90 day record, eligible women will begin designated treatment on day 1 of the next episode of bleeding or spotting. Analysis of the subsequent menstrual pattern will begin from day 1 of that bleeding/spotting episode and will continue through 90 days.
Detailed Description
This is a double blind, placebo controlled, randomised study with an additional randomised non-blinded arm. Two hundred women between the ages of 18-45 years, who are Implanon users with prolonged or frequent breakthrough bleeding (WHO definition) will be recruited and randomised into 4 equal-sized treatment groups of 50 women assigned to Marvelon 7 days or 21 days, NuvaRing 21 days or placebo. Recruited subjects will maintain a daily menstrual diary chart for a minimum of 90 days prior to randomisation, and will be enrolled into the treatment phase provided that they have met one of the World Health Organization criteria for prolonged or frequent bleeding (in the 90 day reference period one episode of bleeding and/or spotting lasting > 10 days, or more than 4 bleeding/spotting episodes). Randomisation will be performed by computer generation of a random number table in blocks of ten, with equal numbers in each of the four groups. The medications will be packed in sequentially numbered and sealed opaque envelopes (independent of the investigators). Following the initial 90 day record, eligible women will begin designated treatment on day 1 of the next episode of bleeding or spotting. Analysis of the subsequent menstrual pattern will begin from day 1 of that bleeding/spotting episode and will continue through 90 days. Analysis of the pre-treatment menstrual pattern will include the 90 days immediately preceding the bleeding episode in which treatment starts. Women will participate in the study for approximately seven months depending on their bleeding pattern. Data analysis: Data will be analysed on an intention to treat basis, entered on SPSS and analysed prior to breaking the randomisation code. Frequency analyses will be undertaken for demographic data and means (SD) compared to check effectiveness of the randomisation scheme. Total number of days of spotting, bleeding, bleeding and spotting and number of episodes during the pre and post 90 days reference period will be entered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstrual Problem
Keywords
Implanon users, Frequent bleeding, Prolonged bleeding, Comparison of treatments, Placebo controlled, Randomly allocated tretment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Marvelon ,placebo
Arm Type
Active Comparator
Arm Description
7 days daily intake of oral capsule containing "Marvelon" ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms followed by 14 days oral placebo capsules containing starch for 21 day treatment Cycle
Arm Title
Marvelon
Arm Type
Active Comparator
Arm Description
21 days daily intake of oral capsules containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms for one cycle of 21 days
Arm Title
NuvaRing
Arm Type
Active Comparator
Arm Description
21 days NuvaRing contraceptive vaginal ring releasing ethinyl oestradiol 15micrograms plus etonorgestrel 120 micrograms dailyleft in situ for 21 days Treatment will be for 21 days
Arm Title
Starch capsule
Arm Type
Placebo Comparator
Arm Description
21 days daily oral placebo capsules Treatment will be for one 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Marvelon
Other Intervention Name(s)
NuvaRing
Intervention Description
7 days daily intake of oral capsule containing containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms followed by 14 days oral placebo capsules 21 days daily intake of oral capsules containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms 21 days NuvaRing contraceptive vaginal ring releasing ethinyl oestradiol 15micrograms plus etonorgestrel 120 micrograms dailyleft in situ for 21 days 21 days daily oral placebo capsules Treatment will be for one cycle of 21 days
Primary Outcome Measure Information:
Title
The number of days to stop bleeding after initiation of each treatment group and placebo
Description
The number of days to stop bleeding after initiation of each treatment group and placebo determined from menstrual diaries completed by subjects
Time Frame
Within 3 weeks of starting therapy
Secondary Outcome Measure Information:
Title
The mean total number of bleeding and spotting days during the 90 day "treatment" reference period
Description
The mean total number of bleeding and spotting days during the 90 day "treatment" reference period compared with the pre-treatment reference period (calculated as percentage reduction) for each group and a comparison between treatment groups and placebo and compared to the other treatment groups determined from menstrual diaries kept for 90 days prior to starting treatment and for 90 days from initiation of treatment.
Time Frame
Six months after entering study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy women aged 18-45 using the subdermal progestogen-only contraceptive implant and experiencing frequent or prolonged vaginal bleeding Willing to keep a menstrual diary for 6 months Exclusion Criteria: Women who have currently or previously had Heart attack or stroke Blood clot in a vein High blood pressure Severe liver or kidney disease Blood pressure > 135 mm systolic or >85 mm diastolic Migraine with aura Breast cancer or any genital cancer Severe chronic liver or kidney disease Women with known sensitivity to ethinyl oestradiol, progestogens Women taking phenytoin, carbamazepine or phenobarbitol Women who are pregnant Women who are lactating Women who are unwilling to keep a daily menstrual diary or otherwise unwilling to follow the study criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edith Weisberg, MB BS MM FRANZCOG
Phone
+61 2 8752 4342
Email
edithw@fpnsw.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Lorraine Edney, RN
Phone
+61 2 8752 4381
Email
lorrainee@fpnsw.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edith Weisberg, MB BS MM
Organizational Affiliation
Family Planning NSW
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian S FRASER, BSC MD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sydney centre for Reproductive Health Research, FPNSW
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2131
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edith Weisberg, MB BS MM

12. IPD Sharing Statement

Citations:
PubMed Identifier
19369294
Citation
Weisberg E, Hickey M, Palmer D, O'Connor V, Salamonsen LA, Findlay JK, Fraser IS. A randomized controlled trial of treatment options for troublesome uterine bleeding in Implanon users. Hum Reprod. 2009 Aug;24(8):1852-61. doi: 10.1093/humrep/dep081. Epub 2009 Apr 15.
Results Reference
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New Treatments for Troublesome Bleeding in Implanon Users

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